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Copanlisib + Ketogenic Diet for Follicular Lymphoma
Study Summary
This trial is testing a new cancer drug in combination with a ketogenic diet in patients with either relapsed or refractory follicular lymphoma or endometrial cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT02631590Trial Design
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Who is running the clinical trial?
Media Library
- I have follicular lymphoma and have undergone at least two prior treatments.I am a woman who can have children and have a recent negative pregnancy test.I do not have any health conditions that would make it unsafe for me to take a new drug.I am HIV positive with an undetectable viral load.I still have side effects from chemotherapy I received over 3 weeks ago.I have heart pain or symptoms related to heart disease.I am still recovering from major surgery complications.I am not taking strong CYP3A4 inhibitor medications.I have not had a heart attack in the last 6 months.I have had kidney stones or they were found during a scan. I also have a known selenium deficiency.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.My endometrial cancer cannot be treated with surgery or standard therapies.My blood pressure is controlled and has been stable on medication for at least a month.I do not have a serious infection worse than a moderate level.I have no active cancer except for certain skin, prostate, or cervical conditions.My organ functions are within normal ranges as per recent tests.My diabetes is not well-controlled (HbA1c > 7.5%).I am being treated for Type II diabetes with specific medications or insulin.I have available tumor tissue samples for diagnosis and biomarker testing.I have heart failure classified as moderate to severe, or my heart's pumping ability is significantly reduced.I have a history of severe or uncontrolled gout or high uric acid levels.I am 18 years old or older.I haven't had chemotherapy, radiotherapy, or unstable steroids recently.I haven't had a stroke or blood clot in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.
- Group 1: Endometrial Cancer (EC)
- Group 2: Follicular Lymphoma (FL)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there negative side effects to taking Copanlisib?
"Copanlisib is still in Phase 2 clinical trials, so there is some data supporting its safety but not yet any efficacy."
Is this a trial that is testing an innovative treatment?
"Since 2012, Bayer has been studying Copanlisib in clinical trials. The first ever trial was completed that same year and involved 227 patients. After the initial study, Phase 2 drug approval was received in 2012. As of now, there are 34 live trials being conducted in 983 cities across 46 different countries."
What are some other instances where Copanlisib has been used in medical research?
"Currently, there are 34 ongoing clinical trials investigating Copanlisib. Of these, 3 have reached Phase 3. The majority of research locations for Copanlisib are situated in Houston, Texas; however, 2139 medical centres worldwide are running studies concerning this treatment."
How many people are being given this treatment as part of the research study?
"That is correct, the listing on clinicaltrials.gov specifies that this trial is currently recruiting patients. This particular study was first made public on December 1st 2021 and received its most recent update on November 24th 2021. The research team needs to enroll 42 individuals from 3 different hospitals or clinics."
Are there any unfilled positions in this clinical research project?
"That is correct. The information available on clinicaltrials.gov suggests that this trial is still looking for patients. This particular study was first posted on December 1st, 2021 and was most recently updated on November 24th, 2021. They are 42 patients remaining to be recruited from 3 different sites."
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